Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
EC10-240
Study information
Scientific title
Randomised analysis, double blind and controlled with placebo of the utility of the extract of cranberry in the prevention of the enterocolitis of premature infants
Acronym
Study hypothesis
The blueberry extract has been used by mankind for over 200 years for indications related to the inhibition of bacterial adherence to epithelia, during this period, no adverse side effects have been reported. Through the prism of non-stick and anti-inflammatory activity of the polyphenols contained in the bilberry extract and its proven utility in the prophylaxis of other processes we propose the following hypothesis:
1. The blueberry extract (Vaccinium macrocarpon) is effective in the prevention of necrotising enterocolitis (NEC) in preterm infants, the equivalent of multimodal therapy given by G. Schmolze et. al., thus resulting in a reduced risk of NEC in more than 3.8%, without prescribing antibiotics
2. The microbiological changes of the intestinal flora induced premature newborn blueberry extract are in the spirit of fostering a proper bowel movements and digestive tolerance earlier than the placebo
Ethics approval(s)
Ethics Committee San Cecilio Hospital (Spain) - not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Necrotising enterocolitis
Intervention
1. Receive a dose of 0.5 ml of the prepared speech in the Pharmacy Department as unidosis in opaque vials. Opaque nasogastric administration every 12 hours.
2. (Placebo) - Receive a dose of 0.5 ml of the prepared speech in the Pharmacy Department as unidosis in opaque vials. Opaque nasogastric administration every 12 hours.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Blueberry extract (Vaccinium macrocarpon)
Primary outcome measure
1. Enterocolitis
2. The follow-up of each patient is 1 month
3. The total test duration is 3 years
Secondary outcome measures
1. Poliphenols in urine
2. The follow-up of each patient is 1 month
3. The total test duration is 3 years
Overall study start date
01/01/2011
Overall study end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Preterm infants less than 1800 g birth weight, either sex
2. Infants with gestational age less than 32 weeks (depending FUR)
Participant type(s)
Patient
Age group
Neonate
Sex
Both
Target number of participants
238
Participant exclusion criteria
1. Newborns multiple malformations
2. Early neonatal sepsis
3. Does not provide consent to participate in the study
Recruitment start date
01/01/2011
Recruitment end date
31/12/2013
Locations
Countries of recruitment
Spain
Study participating centre
Hospital Clínico San Cecilio
Granada
18012
Spain
Sponsor information
Organisation
Department of Health [Ministerio de Sanidad] (Spain)
Sponsor details
Unidad de Subvenciones para la Investigación
Dirección General de Farmacia y Productos Sanitarios
Ministerio de Sanidad y Política Social
C/ Paseo del Prado 18-20
Madrid
281071
Spain
Sponsor type
Government
Website
http://www.msps.es/en/home.htm
ROR
Funders
Funder type
Government
Funder name
Ministerio de Sanidad (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|